A new take on bone density retesting

Screening creates drug customers. Keep this little-known consumer beware maxim in mind when you read the new finding about bone density retesting.  Frequent screening bone scans, starting in early middle-age, have been the norm ever since osteoporosis was discovered in the 1980s. (Believe me, no one ever heard of osteoporosis before then, other than the few health professionals who cared for people of advanced old age.)  The new study shows that women whose first test at age 67 indicates normal bone density can safely delay having a second test for as long as 15 years.  There was a time, not so long ago, when women were advised to start bone density testing right after menopause. But then again, there was also a time when the diagnosis of osteoporosis was not made until a person suffered a fragility fracture.

Before I describe the new study, an historical context is in order. Merck, maker of the first osteoporosis drug, may also have been the first company to establish a winning “formula” for blockbuster drugs: 1) lower the cutoff point for the diagnosis of osteoporosis, better yet, fund a meeting in a beautiful place (like Italy) of high-profile osteoporosis researchers (aka, hired “consultants”) who will do it for you; 2) mount an “osteoporosis awareness” campaign to scare women into thinking the risk of hip fracture starts soon after menopause; 3) expand your market share with frequent mention of a new “disease” called osteopenia, a diagnosis that can be given to anyone who almost has osteoporosis; 4) encourage use of a new screening technology for identifying “at risk” women, and do it with an ad campaign that doesn’t mention your drug so it looks educational; 5) provide financial incentives to doctors who want to purchase screening equipment for their offices; 6) introduce your new drug Fosamax, which received FDA approval in 1995 and soon became a top-selling drug worldwide, despite its minimal effectiveness in reducing the chance of having a hip fracture (1%).  For more, read “The Marketing of Osteoporosis.”

Now for the study that appeared today in The New England Journal of Medicine. It followed nearly 5,000 women, 67 or older, with normal bone density at the hip and no history of hip or spinal fractures, or osteoporosis treatment. The research team led by Margaret L. Gourlay, MD, University of North Carolina, took off from the current advice that women should start having bone-density tests at age 65. This study was designed to determine how long it took for osteoporosis (defined as bone mineral density T score, −2.50 or lower) to develop in women with normal bone density or osteopenia.

The women were followed for 10 to 15 years. The findings were unexpected, according to Dr. Gourlay, who told the New York Times that she and her colleagues were surprised by how slowly osteoporosis progressed. Osteoporosis developed in fewer than 10% of the women who started the study with normal bone density and in fewer than 10% who had either “mild or moderate osteopenia.”  (And I was surprised that the New England Journal of Medicine would allow researchers to use the industry-created term osteopenia.) In summary, women with normal bone density or “mild osteopenia” at age 67 can safely delay having a second bone density test for 15 years.

I hope that word gets out to women about this study because it should cut back on the overuse of bone-density tests, as well as the overuse of Fosamax and other drugs in the same class called bisphosphonates (e.g., Boniva, Actonel, etc.). The test was initially portrayed to women and doctors as predictive of who is likely to suffer a hip fracture.  But Canadian consumer advocate Barbara Mintzes, University of British Columbia, had a more realistic take on this claim over ten years ago: “Bone mineral density testing is a poor predictor of future fractures, but an excellent predictor of start of drug use.” The overwhelming majority of hip fractures, by the way, occur after the age of 70.

Something to think about: Most medical research is now funded by industry, particularly the companies that make drugs, devices, and testing equipment. This study was funded by the U. S. National Institutes of Health.

For information about these serious adverse events associated with these drugs, read “Drugs for bone loss.”   And read this to learn why women should stop taking them after five years.  And here is Dr. Susan Love’s description of how bisphosphonate drugs work and why no one should be surprised that they are causing problems.

This post has been revised to reflect the following correction, added January 21, 2012.

The first version of this article, posted January 19, misstated the conclusion of this study.  The authors did not specify when women should be retested.  The original title of this post and the post itself have been changed accordingly.

Maryann Napoli, Center for Medical Consumers(c)

Drugs for bone loss

It’s never fails to amaze me how long a drug can be in use before its benefits and harms are fully understood. This is particularly troubling where it concerns drugs given to healthy people to prevent something that might happen to them sometime in the future. On my mind right now is the bone drug Fosamax prescribed since the mid-1990s to symptomless women with bone loss usually detected on a bone density measurement test.

Concern over the lack of good information about this widely prescribed drug and it multiple knockoffs (Actonel, Boniva, Didronel, Reclast, Aredia) has galvanized several research teams around the world. The impetus is the unusual thigh bone fractures initially reported over six years ago in women taking Fosamax click here. The international researchers analyzed all relevant studies to determine whether these bone drugs “prevent or cause bone fractures”. Their unenthusiastic conclusion: The drugs have “some effectiveness” in preventing vertebral fractures in the short-term (one to three years). Brace yourself for this clarification: Effectiveness is limited to “vertebral fractures demonstrated by x-ray” (translation: tiny symptomless spinal fractures that the women themselves are unaware of). The researchers go on to point out, “The efficacy with regard to preventing hip fractures is uncertain.”

Wait a minute…wasn’t hip fracture prevention the big selling point of Fosamax and its knockoffs? Remember those scary statistics indicating how many of us would die within the year of a hip fracture.

The harms of these bone drugs are usually determined to be rare, for example, the rotting jawbones (osteonecrosis of the jaw) of women given oral surgery while on Fosamax click here. So are the esophageal ulcers and those spontaneous thigh bone fractures we’ve been hearing about for at least five years. Has anyone tallied up all these “rare” harms so they can be weighed against the small, uncertain benefits of bone drugs? The researchers addressed this question, but said, in effect, “Hold off, we still don’t have a good count yet”. In other words, people on one of these bone drugs are participating in one long, ongoing experiment.

Most of the studies, by the way, were done on Fosamax because it has the longest track record. There is no evidence that the other drugs in this class known as bisphosphonates are any safer or more effective because no head-to-head comparison has been done.

In case you’re wondering how these drugs got FDA approval in the first place, the new analysis gives a brief history. Merck, maker of Fosamax, had only to prove its drug increased bone density… on the shaky assumption that this would translate to fracture prevention. (To gain FDA approval, drug makers test their products against a placebo which means they need only to prove their drug is better than nothing.) In time, the aforementioned x-ray evidence of fracture reduction became acceptable proof of a bone drug’s effectiveness. Only a third of the people with vertebral fractures that show up on x-ray have symptoms.

By 2006 long-term data came from a trial, known by its acronym FLEX, that followed women taking Fosamax for three to ten years. The aim of this trial was to determine whether Fosamax can achieve what matters most to women taking this drug: Does it reduce hip fractures? It found no significant difference between Fosamax and placebo in terms of preventing any type of fracture.

And so it goes. This new analysis is available online at Therapeutics Initiative, published by the University of British Columbia (UBC), Vancouver, click here. It is based on the combined findings of the Cochrane Collaboration and other independent groups in France and Spain. The conclusion: “Given that bisphosphonates can cause severe adverse effects including fractures, which they are meant to prevent, it is urgent that the overall benefits and harms of long-term treatment be clarified. The available evidence suggests that the benefit-harm balance may be unfavorable for their use in osteoporosis.”

The UBC research team plans to take it from there and conduct “a full systematic review and critical appraisal of this widely prescribed class of drugs.”

More to consider about these drugs
-If you have no bone symptoms and have decided that you’ll never take one of these drugs, think twice about having your bone density measured. This screening test is all about unproven predictions of who will suffer a fracture after age 70 and directing them to long-term drug therapy.

-If you think you’ve been injured by a bisphosphonate drug, contact the FDA’s Medwatch Program click here.

Maryann Napoli, Center for Medical Consumers©

Osteoporosis drugs

Older women have long been encouraged to have their bone density measured periodically. And many who followed the advice have walked away with a prescription for Fosamax. Not surprisingly, the promotion of bone density testing has been spearheaded by Merck, maker of Fosamax, which is widely prescribed to women with bone loss. A decade after Fosamax became available in 1995 medical journals began reporting an apparently rare side effect. Spontaneous fractures of the thighbone called atypical subtrochanteric femur fractures occurred in women who had taken Fosamax for more than six years. All the drugs in the same class, known as bisphosphonates (Actonel, Fosamax, Boniva, Reclast), were under suspicion of causing this unusual fracture. In June 2008, the Food and Drug Administration requested patient data from all companies that make bisphosphonate drugs. The FDA has finished its review and recently posted this conclusion on its Web site:

“At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.” Click here for entire FDA posting.

Another Fosamax Adverse Effect?

A possible connection between bisphosphonates and another rare side effect called osteonecrosis of the jaw will be tested in court, according to recent ruling. A federal judge refused to dismiss 40 lawsuits against the Novartis Corp, maker of bisphosphonates Aredia and Zometa. Novartis is accused of failure to warn patients that these drugs can cause destruction of the jawbone, primarily in people with advanced cancer given one of these drugs intravenously. Osteonecrosis of the jaw appears to be associated with certain dental procedures. When case reports of this injury first appeared in a medical journal over five years ago, these untreatable injuries were thought to be confined solely to cancer patients given high doses of a bisphosphonate intravenously. In time, however, similar injuries were reported in long-term users of oral bisphosphonates. Read “Osteonecrosis of the jaw—more common than previously thought.”

More information
Bisphosphonate drugs are better at improving bone density than they are at reducing the chances of having a hip fracture in old age. For more, read my 2009 article for the American Journal of Nursing called “The marketing of osteoporosis—how a risk factor became a disease.”

Maryann Napoli, Center for Medical Consumers©

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